{"success":true,"data":{"pressRelease":{"id":"34623","rtpr_id":"nBw8nLwFRa","ticker":"AZN","exchange":"LSE","all_tickers":["AZN"],"title":"Perioperative IMFINZI® (durvalumab) plus neoadjuvant EV showed statistically significant and clinically meaningful improvements in event-free survival and overall survival in muscle-invasive bladder cancer in the Phase III VOLGA trial","author":"Business Wire","published_at":"2026-05-14T11:00:00.543Z","article_body":"Perioperative IMFINZI® (durvalumab) plus neoadjuvant EV showed statistically\nsignificant and clinically meaningful improvements in event-free survival and\noverall survival in muscle-invasive bladder cancer in the Phase III VOLGA\ntrial\n\nPerioperative IMFINZI plus IMJUDO® (tremelimumab-actl) and neoadjuvant EV\nshowed a statistically significant and clinically meaningful improvement in\nevent-free survival and a favorable trend for overall survival\n\nHigh-level results from a planned interim analysis of the VOLGA Phase III\ntrial showed perioperative treatment with IMFINZI(®) (durvalumab) in\ncombination with neoadjuvant enfortumab vedotin (EV) demonstrated\nstatistically significant and clinically meaningful improvements in event-free\nsurvival (EFS) and overall survival (OS) in patients with muscle-invasive\nbladder cancer (MIBC) versus standard of care. Patients were ineligible for or\nhad declined cisplatin-based chemotherapy. Patients in the comparator arm had\na radical cystectomy (surgery to remove the bladder) with or without approved\nadjuvant treatment.\n\nPerioperative IMFINZI plus IMJUDO(®) (tremelimumab-actl) in combination with\nneoadjuvant EV demonstrated a statistically significant and clinically\nmeaningful improvement in EFS and a favorable trend for OS; however, the OS\ndata were not statistically significant at this planned interim analysis and\nwill be formally reassessed at a subsequent analysis.\n\nApproximately one in four patients with bladder cancer has muscle-invasive\ndisease, where the tumor invades the muscle wall of the bladder, without\ndistant metastases.(1,2) As many as 50% of patients are ineligible for\ncisplatin-based chemotherapy due to impaired renal function or\ncomorbidities.(3,4) The standard treatment for these patients has historically\nbeen radical cystectomy alone but, despite undergoing this major surgery,\npatients experience high rates of recurrence and have a poor prognosis.(3-5)\n\nThomas Powles, MD, Professor, Chair of Barts Cancer Centre (QMUL), London, UK,\nand International Coordinating Investigator for the trial, said: “Up to half\nof patients with muscle-invasive bladder cancer are not eligible for cisplatin\nand face high rates of disease recurrence, even after having their bladder\nremoved, leaving a significant need for new effective and well-tolerated\ntreatments. The VOLGA results show that perioperative durvalumab significantly\nextends event-free survival and overall survival when combined with\nneoadjuvant enfortumab vedotin, with a manageable safety profile, compared to\nsurgery for patients in this curative-intent setting.”\n\nSusan Galbraith, Executive Vice President, Oncology Haematology R&D,\nAstraZeneca, said: “This interim analysis from the VOLGA trial highlights\nthe benefit of perioperative IMFINZI with neoadjuvant enfortumab vedotin\ncompared to surgery, a novel regimen that optimizes treatment options for\npatients. Together with NIAGARA and POTOMAC, VOLGA is our third positive\nreadout in bladder cancer, setting a strong foundation for IMFINZI as the\nimmunotherapy backbone in this early-stage, curative-intent setting.”\n\nThe safety and tolerability of IMFINZI with or without IMJUDO plus EV was\nconsistent with the known safety profiles of the individual medicines, with no\nnew safety signals identified. These data will be presented at a forthcoming\nmedical meeting and shared with global regulatory authorities.\n\nIMFINZI is approved in over 40 countries for patients with cisplatin-eligible\nMIBC, based on the NIAGARA Phase III trial. Additionally, IMFINZI added to\nBacillus Calmette-Guérin therapy met the primary endpoint of disease-free\nsurvival for patients with high-risk non-muscle-invasive bladder cancer in the\nPOTOMAC Phase III trial and is currently under review in the US, European\nUnion (EU), Japan and several other countries. IMFINZI is also being\ninvestigated in locally advanced or metastatic disease in the NILE Phase III\ntrial.\n\nIMPORTANT SAFETY INFORMATION\n\nThere are no contraindications for IMFINZI(®) (durvalumab) or IMJUDO(®)\n(tremelimumab-actl).\n\nSevere and Fatal Immune-Mediated Adverse Reactions\n\nImportant immune-mediated adverse reactions listed under Warnings and\nPrecautions may not include all possible severe and fatal immune-mediated\nreactions. Immune-mediated adverse reactions, which may be severe or fatal,\ncan occur in any organ system or tissue. Immune-mediated adverse reactions can\noccur at any time after starting treatment or after discontinuation. Monitor\npatients closely for symptoms and signs that may be clinical manifestations of\nunderlying immune-mediated adverse reactions. Evaluate clinical chemistries\nincluding liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level,\nand thyroid function at baseline and before each dose. In cases of suspected\nimmune-mediated adverse reactions, initiate appropriate workup to exclude\nalternative etiologies, including infection. Institute medical management\npromptly, including specialty consultation as appropriate. Withhold or\npermanently discontinue IMFINZI and IMJUDO depending on severity. See USPI\nDosing and Administration for specific details. In general, if IMFINZI and\nIMJUDO requires interruption or discontinuation, administer systemic\ncorticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until\nimprovement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate\ncorticosteroid taper and continue to taper over at least 1 month. Consider\nadministration of other systemic immunosuppressants in patients whose\nimmune-mediated adverse reactions are not controlled with corticosteroid\ntherapy.\n\nImmune-Mediated Pneumonitis\n\nIMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal.\nThe incidence of pneumonitis is higher in patients who have received prior\nthoracic radiation.\n\n\n * IMFINZI as a Single Agent\n\n\n* In patients who did not receive recent prior radiation, the incidence of\nimmune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%),\nand Grade 3-4 (0.4%) adverse reactions.\n\n * In patients who received recent prior radiation, the incidence of pneumonitis\n(including radiation pneumonitis) in patients with unresectable Stage III\nNSCLC following definitive chemoradiation within 42 days prior to initiation\nof IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and\n12.8% (30/234) in patients receiving placebo. Of the patients who received\nIMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.\n\n * The incidence of pneumonitis (including radiation pneumonitis) in patients\nwith LS-SCLC following chemoradiation within 42 days prior to initiation of\nIMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6%\n(16/265) in patients receiving placebo. Of the patients who received IMFINZI\n(262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse\nreactions.\n\n * The frequency and severity of immune-mediated pneumonitis in patients who did\nnot receive definitive chemoradiation prior to IMFINZI were similar in\npatients who received IMFINZI as a single agent or with ES-SCLC or BTC when\ngiven in combination with chemotherapy.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving\nIMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse\nreactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nfatal (0.5%), and Grade 3 (1%) adverse reactions.\n\n\n\n\nImmune-Mediated Colitis\n\nIMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated\ncolitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated\ncolitis that is frequently associated with diarrhea. Cytomegalovirus (CMV)\ninfection/reactivation has been reported in patients with\ncorticosteroid-refractory immune-mediated colitis. In cases of\ncorticosteroid-refractory colitis, consider repeating infectious workup to\nexclude alternative etiologies.\n\n\n * IMFINZI as a Single Agent\n\n\n* Immune-mediated colitis occurred in 2% (37/1889) of patients receiving\nIMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients\nreceiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.\nIntestinal perforation has been observed in other studies of IMFINZI and\nIMJUDO.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy including\nfatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and\nlarge intestine perforation were reported in 0.1% of patients.\n\n\n\n\nImmune-Mediated Hepatitis\n\nIMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.\n\n\n * IMFINZI as a Single Agent\n\n\n* Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving\nIMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse\nreactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving\nIMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%)\nadverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nfatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.\n\n\n\n\nImmune-Mediated Endocrinopathies\n\n\n * Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary\nadrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate\nsymptomatic treatment, including hormone replacement as clinically indicated.\n\n\n* IMFINZI as a Single Agent\n\n\n* Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients\nreceiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients\nreceiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients\nreceiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy,\nincluding Grade 3 (0.8%) adverse reactions.\n\n\n\n\n\n\n\n * Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis.\nHypophysitis can present with acute symptoms associated with mass effect such\nas headache, photophobia, or visual field cuts. Hypophysitis can cause\nhypopituitarism. Initiate symptomatic treatment including hormone replacement\nas clinically indicated.\n\n\n* IMFINZI as a Single Agent\n\n\n* Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of\npatients\nwho received IMFINZI.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of\npatients receiving IMFINZI and IMJUDO.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.5%) adverse reactions.\n\n\n\n\n\n\n\n * Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism): IMFINZI\nand IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can\npresent with or without endocrinopathy. Hypothyroidism can follow\nhyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or\ninstitute medical management of hyperthyroidism as clinically indicated.\n\n\n* IMFINZI as a Single Agent\n\n\n* Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving\nIMFINZI, including Grade 3 (<0.1%) adverse reactions.\n\n * Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients\nreceiving IMFINZI.\n\n * Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients\nreceiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving\nIMFINZI and IMJUDO.\n\n * Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients\nreceiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.\n\n * Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving\nIMFINZI and IMJUDO.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy.\n\n * Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.2%) adverse reactions.\n\n * Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.5%) adverse reactions.\n\n\n\n\n * IMFINZI with Carboplatin and Paclitaxel\n\n\n* Immune-mediated hypothyroidism occurred in 14% (34/235) of patients\nreceiving\nIMFINZI in combination with carboplatin and paclitaxel.\n\n\n\n\n\n\n\n * Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis:\nMonitor patients for hyperglycemia or other signs and symptoms of diabetes.\nInitiate treatment with insulin as clinically indicated.\n\n\n* IMFINZI as a Single Agent\n\n\n* Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1%\n(1/1889)\nof patients receiving IMFINZI.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin\ntherapy that had not resolved at last follow-up.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of\npatients\nreceiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy\nincluding Grade 3 (0.3%) adverse reactions.\n\n\n\n\n\n\n\nImmune-Mediated Nephritis with Renal Dysfunction\n\nIMFINZI and IMJUDO can cause immune-mediated nephritis.\n\n\n * IMFINZI as a Single Agent\n\n\n* Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving\nIMFINZI, including Grade 3 (<0.1%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated nephritis occurred in 1% (4/388) of patients receiving\nIMFINZI\nand IMJUDO, including Grade 3 (0.5%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.2%) adverse reactions.\n\n\n\n\nImmune-Mediated Dermatology Reactions\n\nIMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative\ndermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with\neosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis\n(TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical\nemollients and/or topical corticosteroids may be adequate to treat mild to\nmoderate non-exfoliative rashes.\n\n\n * IMFINZI as a Single Agent\n\n\n* Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients\nreceiving IMFINZI, including Grade 3 (0.4%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients\nreceiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%)\nadverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients\nreceiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy,\nincluding Grade 3 (0.3%) adverse reactions.\n\n\n\n\nImmune-Mediated Pancreatitis\n\nIMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis.\nImmune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving\nIMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse\nreactions.\n\nOther Immune-Mediated Adverse Reactions\n\nThe following clinically significant, immune-mediated adverse reactions\noccurred at an incidence of less than 1% each in patients who received IMFINZI\nand IMJUDO or were reported with the use of other immune-checkpoint\ninhibitors.\n\n\n * Cardiac/vascular: Myocarditis, pericarditis, vasculitis.\n\n * Nervous system: Meningitis, encephalitis, myelitis and demyelination,\nmyasthenic syndrome/myasthenia gravis (including exacerbation),\nGuillain-Barré syndrome, nerve paresis, autoimmune neuropathy.\n\n * Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur.\nSome cases can be associated with retinal detachment. Various grades of visual\nimpairment to include blindness can occur. If uveitis occurs in combination\nwith other immune-mediated adverse reactions, consider a\nVogt-Koyanagi-Harada-like syndrome, as this may require treatment with\nsystemic steroids to reduce the risk of permanent vision loss.\n\n * Gastrointestinal: Pancreatitis including increases in serum amylase and lipase\nlevels, gastritis, duodenitis.\n\n * Musculoskeletal and connective tissue disorders: Myositis/polymyositis,\nrhabdomyolysis and associated sequelae including renal failure, arthritis,\npolymyalgia rheumatic.\n\n * Endocrine: Hypoparathyroidism.\n\n * Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic\nlymphohistiocytosis, systemic inflammatory response syndrome, histiocytic\nnecrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune\nthrombocytopenia, solid organ transplant rejection, other transplant\n(including corneal graft) rejection.\n\nInfusion-Related Reactions\n\nIMFINZI and IMJUDO can cause severe or life-threatening infusion-related\nreactions. Monitor for signs and symptoms of infusion-related reactions.\nInterrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO\nbased on the severity. See USPI Dosing and Administration for specific\ndetails. For Grade 1 or 2 infusion-related reactions, consider using\npre-medications with subsequent doses.\n\n\n * IMFINZI as a Single Agent\n\n\n* Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving\nIMFINZI, including Grade 3 (0.3%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Infusion-related reactions occurred in 2.6% (10/388) of patients receiving\nIMFINZI and IMJUDO.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Infusion-related reactions occurred in 2.9% (17/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.3%) adverse reactions.\n\n\n\n\nComplications of Allogeneic HSCT after IMFINZI\n\nFatal and other serious complications can occur in patients who receive\nallogeneic hematopoietic stem cell transplantation (HSCT) before or after\nbeing treated with a PD-1/L-1 blocking antibody. Transplant-related\ncomplications include hyperacute graft-versus-host disease (GVHD), acute GVHD,\nchronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity\nconditioning, and steroid-requiring febrile syndrome (without an identified\ninfectious cause). These complications may occur despite intervening therapy\nbetween PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for\nevidence of transplant-related complications and intervene promptly. Consider\nthe benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior\nto or after an allogeneic HSCT.\n\nEmbryo-Fetal Toxicity\n\nBased on their mechanism of action and data from animal studies, IMFINZI and\nIMJUDO can cause fetal harm when administered to a pregnant woman. Advise\npregnant women of the potential risk to a fetus. In females of reproductive\npotential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and\nadvise them to use effective contraception during treatment with IMFINZI and\nIMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.\n\nLactation\n\nThere is no information regarding the presence of IMFINZI and IMJUDO in human\nmilk; however, because of the potential for serious adverse reactions in\nbreastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed\nduring treatment and for 3 months after the last dose.\n\nAdverse Reactions\n\nUnresectable Stage III NSCLC\n\n\n * In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI\n(n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue\n(34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract\ninfections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4\nadverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation\npneumonitis (3.4%).\n\n * In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI\n(n=475), discontinuation due to adverse reactions occurred in 15% of patients\nin the IMFINZI arm. Serious adverse reactions occurred in 29% of patients\nreceiving IMFINZI. The most frequent serious adverse reactions (≥2%) were\npneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal\npneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of\npatients and were similar across arms.\n\nResectable NSCLC\n\n\n * In patients with resectable NSCLC in the AEGEAN study, the most common adverse\nreactions (occurring in ≥20% of patients) were anemia, nausea, constipation,\nfatigue, musculoskeletal pain, and rash.\n\n * In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study\nreceiving IMFINZI in combination with platinum-containing chemotherapy\n(n=401), permanent discontinuation of IMFINZI due to an adverse reaction\noccurred in 6.7% of patients. Serious adverse reactions occurred in 21% of\npatients. The most frequent (≥1%) serious adverse reactions were pneumonia\n(2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia\n(1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of\npatients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%),\nmyocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death\nnot otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who\nreceived neoadjuvant treatment and 398 placebo-treated patients who received\nneoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive\nsurgery due to adverse reactions.\n\n * In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study\nreceiving IMFINZI as a single agent (n=265), permanent discontinuation of\nIMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse\nreactions occurred in 13% of patients. The most frequent serious adverse\nreactions reported in >1% of patients were pneumonia (1.9%), pneumonitis\n(1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the\nadjuvant phase of the study, including COVID-19 pneumonia, pneumonia\naspiration, interstitial lung disease and aortic aneurysm.\n\nMetastatic NSCLC\n\n\n * In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO\nplus platinum-based chemotherapy (n=330), the most common adverse reactions\n(occurring in ≥20% of patients) were nausea (42%), fatigue (36%),\nmusculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea\n(22%).\n\n * In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination\nwith IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation\nof IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients.\nSerious adverse reactions occurred in 44% of patients, with the most frequent\nserious adverse reactions reported in at least 2% of patients being pneumonia\n(11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%),\nand febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of\n4.2% of patients.\n\nLimited-stage Small Cell Lung Cancer\n\n\n * In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI\n(n=262), the most common adverse reactions occurring in ≥20% of patients\nreceiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue\n(21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis\nor radiation pneumonitis and pneumonia.\n\n * In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI\n(n=262), IMFINZI was permanently discontinued due to adverse reactions in 16%\nof the patients receiving IMFINZI. Serious adverse reactions occurred in 30%\nof patients receiving IMFINZI. The most frequent serious adverse reactions\nreported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation\npneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in\n2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac\nfailure, encephalopathy and pneumonitis (0.4% each).\n\nExtensive-stage Small Cell Lung Cancer\n\n\n * In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI\nplus chemotherapy (n=265), the most common adverse reactions (≥20%) were\nnausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common\nGrade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%).\n\n * In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI\nplus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions\nin 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse\nreactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The\nmost frequent serious adverse reactions reported in at least 1% of patients\nwere febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia\n(1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred\nin 4.9% of patients receiving IMFINZI plus chemotherapy.\n\nLocally Advanced or Metastatic Biliary Tract Cancers\n\n\n * In patients with locally advanced or metastatic BTC in the TOPAZ-1 study\nreceiving IMFINZI (n=338), the most common adverse reactions (occurring in\n≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%),\ndecreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).\n\n * In patients with locally advanced or metastatic BTC in the TOPAZ-1 study\nreceiving IMFINZI (n=338), discontinuation due to adverse reactions occurred\nin 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse\nreactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The\nmost frequent serious adverse reactions reported in at least 2% of patients\nwere cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%) and acute\nkidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients\nreceiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic\nstroke (4 patients), sepsis (2 patients), and upper gastrointestinal\nhemorrhage (2 patients).\n\nUnresectable Hepatocellular Carcinoma\n\n\n * In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and\nIMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of\npatients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%),\nmusculoskeletal pain (22%), and abdominal pain (20%).\n\n * In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and\nIMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious\nadverse reactions in >1% of patients included hemorrhage (6%), diarrhea\n(4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute\nkidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in\n8% of patients who received IMFINZI and IMJUDO, including death (1%),\nhemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%),\nhepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent\ndiscontinuation of treatment regimen due to an adverse reaction occurred in\n14% of patients.\n\nPrimary advanced or Recurrent dMMR Endometrial Cancer\n\n\n * In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E\nstudy receiving IMFINZI in combination with carboplatin and paclitaxel\nfollowed by IMFINZI as a single agent (n=44), the most common adverse\nreactions, including laboratory abnormalities (occurring in >20% of\npatients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea\n(59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation\n(39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased\nAST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium\n(25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%),\nand decreased appetite (18%). The most common Grade 3 or 4 adverse reactions\n(≥3%) were constipation (4.5%) and fatigue (4.5%).\n\n * In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E\nstudy receiving IMFINZI in combination with carboplatin and paclitaxel\nfollowed by IMFINZI as a single agent (n=44), permanent discontinuation of\nIMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse\nreactions occurred in 30% of patients who received IMFINZI with carboplatin\nand paclitaxel; the most common serious adverse reactions (≥4%) were\nconstipation (4.5%) and rash (4.5%).\n\nMuscle-Invasive Bladder Cancer (MIBC)\n\n\n * In patients with MIBC, the most common adverse reactions, including laboratory\nabnormalities, in the overall study (occurring in ≥20% of patients) were\ndecreased hemoglobin, decreased neutrophils, increased blood creatinine,\ndecreased sodium, nausea, increased ALT, decreased calcium, decreased\nplatelets, fatigue, increased potassium, decreased lymphocytes, increased AST,\nconstipation, decreased magnesium, decreased appetite, increased alkaline\nphosphate, rash, pyrexia, diarrhea, vomiting and abdominal pain.\n\n * In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving\nIMFINZI in combination with gemcitabine and cisplatin (n=530), permanent\ndiscontinuation of IMFINZI due to an adverse reaction occurred in 9% of\npatients. Serious adverse reactions occurred in 24% of patients; the most\nfrequent (≥1%) serious adverse reactions were pulmonary embolism (1.9%),\nfebrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia\n(1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse\nreactions occurred in 1.1% of patients including sepsis, myocardial\ninfarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of\npneumonia was reported in 1 (0.2%) patient in the post-surgery phase before\nadjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm\nand 526 patients in the chemotherapy treatment arm who received neoadjuvant\ntreatment, 1 (0.2%) patient in each treatment arm did not receive surgery due\nto adverse reactions. The adverse reaction that led to cancellation of surgery\nin the IMFINZI treatment arm was interstitial lung disease.\n\n * In patients with MIBC in the adjuvant phase of the NIAGARA study receiving\nIMFINZI as a single agent (n=383), permanent discontinuation of adjuvant\nIMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse\nreactions occurred in 26% of patients. The most frequent serious adverse\nreactions (occurring in ≥1% of patients) were urinary tract infection (7%),\nacute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%),\nurosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8%\nof patients, including COVID-19, severe acute respiratory syndrome,\ncardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic\nfailure (0.3% each).\n\nResectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)\n\n\n * In patients with resectable GC/GEJC, the most common adverse reactions in the\noverall study (occurring in ≥20% of patients) were diarrhea, nausea,\nperipheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal\npain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.\n\n * In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN\nstudy receiving IMFINZI in combination with FLOT chemotherapy (n=475),\npermanent discontinuation of IMFINZI due to an adverse reaction occurred in\n2.5% of patients. Serious adverse reactions occurred in 21% of patients; the\nmost frequent (≥2%) serious adverse reaction was diarrhea (2.5%). Deaths\noccurred in 1.9% of patients; deaths ≥2 patients included septic shock\n(0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI\n+ FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT\nchemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4%\nof patients, respectively, did not receive surgery due to adverse reactions,\nand 2.3% and 2.6% of patients, respectively, had a delay in surgery due to\nARs.\n\n * In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN\nstudy receiving IMFINZI in combination with FLOT chemotherapy (n=365),\npermanent discontinuation of IMFINZI due to an adverse reaction occurred in 7%\nof patients. Serious adverse reactions occurred in 29% of patients; the most\nfrequent (≥2%) serious adverse reaction was pneumonia (2.5%). Deaths\noccurred in 2.2% of patients; deaths ≥2 patients included gastrointestinal\nperforation (0.5%) and COVID-19 (0.5%).\n\n * In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN\nstudy receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI\ndue to an adverse reaction occurred in 6% of patients. Serious adverse\nreactions occurred in 14% of patients. Deaths occurred in 1.7% of patients;\ndeaths ≥2 patients included gastrointestinal perforation (0.6%) and COVID-19\n(0.6%).\n\nThe safety and effectiveness of IMFINZI and IMJUDO have not been established\nin pediatric patients.\n\nIndications:\n\nIMFINZI, as a single agent, is indicated for the treatment of adult patients\nwith unresectable Stage III non-small cell lung cancer (NSCLC) whose disease\nhas not progressed following concurrent platinum-based chemotherapy and\nradiation therapy (cCRT).\n\nIMFINZI in combination with platinum-containing chemotherapy as neoadjuvant\ntreatment, followed by IMFINZI continued as a single agent as adjuvant\ntreatment after surgery, is indicated for the treatment of adult patients with\nresectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal\ngrowth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)\nrearrangements.\n\nIMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is\nindicated for the treatment of adult patients with metastatic NSCLC with no\nsensitizing EGFR mutations or ALK genomic tumor aberrations.\n\nIMFINZI, as a single agent, is indicated for the treatment of adult patients\nwith limited-stage small cell lung cancer (LS-SCLC) whose disease has not\nprogressed following concurrent platinum-based chemotherapy and radiation\ntherapy (cCRT).\n\nIMFINZI, in combination with etoposide and either carboplatin or cisplatin, is\nindicated for the first-line treatment of adult patients with extensive-stage\nsmall cell lung cancer (ES-SCLC).\n\nIMFINZI, in combination with gemcitabine and cisplatin, is indicated for the\ntreatment of adult patients with locally advanced or metastatic biliary tract\ncancer (BTC).\n\nIMFINZI in combination with IMJUDO is indicated for the treatment of adult\npatients with unresectable hepatocellular carcinoma (uHCC).\n\nIMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as\na single agent is indicated for the treatment of adult patients with primary\nadvanced or recurrent endometrial cancer that is mismatch repair deficient\n(dMMR) as determined by an FDA-approved test.\n\nIMFINZI in combination with gemcitabine and cisplatin as neoadjuvant\ntreatment, followed by single agent IMFINZI as adjuvant treatment following\nradical cystectomy, is indicated for the treatment of adult patients with\nmuscle-invasive bladder cancer (MIBC).\n\nIMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and\ndocetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single\nagent IMFINZI, is indicated for the treatment of adult patients with\nresectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).\n\nPlease see Full Prescribing Information including Medication Guide for IMFINZI\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdrd9vrdh9yh09.cloudfront.net%2F50fd68b9-106b-4550-b5d0-12b045f8b184%2F9496217c-08b3-432b-ab4f-538d795820bd%2F9496217c-08b3-432b-ab4f-538d795820bd_viewable_rendition__v.pdf&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=IMFINZI&index=1&md5=a85a2955e69b19fafb75f06f0ad6bdb0)\nand IMJUDO\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdrd9vrdh9yh09.cloudfront.net%2F50fd68b9-106b-4550-b5d0-12b045f8b184%2F0102c6fd-de8a-4b43-afa3-2a2c2115d472%2F0102c6fd-de8a-4b43-afa3-2a2c2115d472_viewable_rendition__v.pdf&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=IMJUDO&index=2&md5=ac45e910f4ba462f9dfc56aaf50e3905)\n.\n\nNotes\n\nBladder cancer\n\nBladder cancer is the 9th most common cancer in the world, with more than\n614,000 cases diagnosed each year.(6) The most common type is urothelial\ncarcinoma, which begins in the urothelial cells of the urinary tract.( 7)\n\nIn 2024, an estimated 117,500 patients were treated for MIBC with the standard\nof care, which included neoadjuvant cisplatin-based chemotherapy and radical\ncystectomy.(5,8) In 2025, the NIAGARA Phase III trial established a new\nstandard by adding perioperative IMFINZI to the regimen.(9) However, up to\nhalf of patients are not eligible to receive cisplatin, and approximately 50%\nof MIBC patients who undergo bladder removal surgery experience disease\nrecurrence.(3,5) New treatment options that prevent both progression before\nsurgery and recurrence after surgery are critically needed in this\ncurative-intent setting.\n\nVOLGA\n\nVOLGA is a Phase III, randomized, open-label, multi-center global trial\nevaluating perioperative IMFINZI(®) (durvalumab) with or without IMJUDO(®)\n(tremelimumab-actl) in combination with neoadjuvant EV as treatment for\npatients with MIBC undergoing radical cystectomy who are not eligible for or\nhave declined cisplatin compared to radical cystectomy with or without\napproved adjuvant therapy. In the trial, 695 patients were randomized 1:1:1 to\nArm 1 (three cycles of IMFINZI and EV, plus two cycles of IMJUDO prior to\nsurgery, followed by nine cycles of IMFINZI plus one cycle of IMJUDO as\nadjuvant therapy), Arm 2 (three cycles of IMFINZI and EV prior to surgery,\nfollowed by nine cycles of IMFINZI adjuvant monotherapy) and Arm 3, the\ncomparator arm.\n\nThe trial was conducted in 182 centers across 25 countries in Europe, North\nAmerica, South America and Asia. Its dual primary endpoints are EFS, defined\nas the time from randomization to first recurrence post-radical cystectomy,\nfirst progression in patients who did not undergo radical cystectomy, failure\nto undergo radical cystectomy in patients with residual disease or death due\nto any cause, for both experimental arms versus the comparator arm. Secondary\nendpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic\ncomplete response, disease-free survival and pathologic downstaging across\nboth experimental arms.\n\nIMFINZI\n\nIMFINZI(®) (durvalumab) is a human monoclonal antibody that binds to the\nPD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80\nproteins, countering the tumor’s immune-evading tactics and releasing the\ninhibition of immune responses.\n\nIn addition to its indication in MIBC, IMFINZI is the global standard of care\nbased on OS in the curative-intent setting of unresectable, Stage III\nnon-small cell lung cancer (NSCLC) in patients whose disease has not\nprogressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as\na perioperative treatment in combination with neoadjuvant chemotherapy in\nresectable NSCLC, and in combination with a short course of IMJUDO(®)\n(tremelimumab-actl) and chemotherapy for the treatment of metastatic NSCLC.\nIMFINZI is also approved for limited-stage small cell lung cancer (SCLC) in\npatients whose disease has not progressed following concurrent platinum-based\nCRT; and in combination with chemotherapy (etoposide and either carboplatin or\ncisplatin) for the treatment of extensive-stage SCLC.\n\nIn addition to its indications in lung cancers, IMFINZI is approved in\ncombination with chemotherapy (gemcitabine plus cisplatin) in locally advanced\nor metastatic biliary tract cancer and in combination with IMJUDO in\nunresectable hepatocellular carcinoma (HCC). IMFINZI is also approved as a\nmonotherapy in unresectable HCC in Japan and the EU. In resectable gastric and\ngastroesophageal junction cancers, perioperative IMFINZI added to\nstandard-of-care chemotherapy is approved in the US and EU. Additionally, in\nApril 2026, IMFINZI in combination with IMJUDO, lenvatinib and transarterial\nchemoembolization (TACE) demonstrated a statistically significant and\nclinically meaningful improvement in the primary endpoint of progression-free\nsurvival versus TACE alone for patients with unresectable HCC eligible for\nembolization in the EMERALD-3 Phase III trial.\n\nIMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is\napproved as a 1st-line treatment for primary advanced or recurrent endometrial\ncancer (mismatch repair deficient disease only in US and EU). IMFINZI in\ncombination with chemotherapy followed by olaparib and IMFINZI is approved for\npatients with mismatch repair proficient advanced or recurrent endometrial\ncancer in EU and Japan.\n\nSince the first approval in May 2017, more than 414,000 patients have been\ntreated with IMFINZI. As part of a broad development program, IMFINZI is being\ntested as a single treatment and in combinations with other anti-cancer\ntreatments for patients with SCLC, NSCLC, bladder cancer, breast cancer,\nseveral gastrointestinal and gynecologic cancers, and other solid tumors.\n\nIMJUDO\n\nIMJUDO(®) (tremelimumab-actl) is a human monoclonal antibody that targets the\nactivity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). IMJUDO\nblocks the activity of CTLA-4, contributing to T-cell activation, priming the\nimmune response to cancer and fostering cancer cell death. In addition to its\napproved indications in liver and lung cancers, IMJUDO is being tested in\ncombination with IMFINZI across other tumor types including SCLC (ADRIATIC)\nand bladder cancer (NILE).\n\nAstraZeneca in immuno-oncology (IO)\n\nAstraZeneca is a pioneer in introducing the concept of immunotherapy into\ndedicated clinical areas of high unmet medical need. The Company has a\ncomprehensive and diverse IO portfolio and pipeline anchored in\nimmunotherapies designed to overcome evasion of the anti-tumor immune response\nand stimulate the body’s immune system to attack tumors.\n\nAstraZeneca strives to redefine cancer care and help transform outcomes for\npatients with IMFINZI as a monotherapy and in combination with IMJUDO as well\nas other novel immunotherapies and modalities. The Company is also\ninvestigating next-generation immunotherapies like bispecific antibodies and\ntherapeutics that harness different aspects of immunity to target cancer,\nincluding cell therapy and T-cell engagers.\n\nAstraZeneca is pursuing an innovative clinical strategy to bring IO-based\ntherapies that deliver long-term survival to new settings across a wide range\nof cancer types. The Company is focused on exploring novel combination\napproaches to help prevent treatment resistance and drive longer immune\nresponses. With an extensive clinical program, the Company also champions the\nuse of IO treatment in earlier disease stages, where there is the greatest\npotential for cure.\n\nAstraZeneca in oncology\n\nAstraZeneca is leading a revolution in oncology with the ambition to provide\ncures for cancer in every form, following the science to understand cancer and\nall its complexities to discover, develop and deliver life-changing medicines\nto patients.\n\nThe Company’s focus is on some of the most challenging cancers. It is\nthrough persistent innovation that AstraZeneca has built one of the most\ndiverse portfolios and pipelines in the industry, with the potential to\ncatalyze changes in the practice of medicine and transform the patient\nexperience.\n\nAstraZeneca has the vision to redefine cancer care and, one day, eliminate\ncancer as a cause of death.\n\nAstraZeneca \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.astrazeneca-us.com%2F&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=AstraZeneca&index=3&md5=fe7416841d82e5b61aeeb441f683ee1a)\n\nAstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical\ncompany that focuses on the discovery, development, and commercialization of\nprescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals,\nincluding Cardiovascular, Renal & Metabolism, and Respiratory &\nImmunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are\nsold in more than 125 countries and used by millions of patients worldwide.\nPlease visit astrazeneca-us.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.astrazeneca-us.com%2F&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=astrazeneca-us.com&index=4&md5=92ae47cad538986c154d1856568aec7f)\nand follow the Company on social media @AstraZeneca\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fastrazeneca&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=%40AstraZeneca&index=5&md5=dc035a938124a6aab6432945147ce7db)\n. The contents of AstraZeneca’s website do not form part of this document\nand no one should rely on such websites or the contents thereof in reading\nthis document.\n\nReferences\n\n\n 1. Burger M, et al. Epidemiology and Risk Factors of Urothelial Bladder Cancer.\nEur Urol. 2013;63(2):234-241.\n\n 2. National Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and\nManagement. London: National Institute for Health and Care Excellence (NICE).\nAvailable at: \nhttps://www.ncbi.nlm.nih.gov/books/NBK356289/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK356289%2F&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK356289%2F&index=6&md5=7153038846a16ef7ca891e4e6cc83207)\n\n. Accessed May 2026.\n\n 3. Dash A, et al. Impact of renal impairment on eligibility for adjuvant\ncisplatin-based chemotherapy in patients with urothelial carcinoma of the\nbladder. Cancer. 2006;107(3):506-513.\n\n 4. Galsky MD, et al. Treatment of patients with metastatic urothelial cancer\n“unfit” for cisplatin-based chemotherapy. J Clin Oncol.\n2011;29(17):2432-2438.\n\n 5. Van der Heijden AG, et al. EAU Guidelines on Muscle-invasive and Metastatic\nBladder Cancer. 2026. Edn. Presented at the EAU Annual Congress Copenhagen\n2026. ISBN 978-94-92671-30-1.\n\n 6. World Health Organization. International Agency for Research on Cancer.\nBladder Fact Sheet. Available at: \nhttps://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fgco.iarc.who.int%2Fmedia%2Fglobocan%2Ffactsheets%2Fcancers%2F30-bladder-fact-sheet.pdf&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fgco.iarc.who.int%2Fmedia%2Fglobocan%2Ffactsheets%2Fcancers%2F30-bladder-fact-sheet.pdf&index=7&md5=6aecaf4f857024cbcf411266f2340fa4)\n\n. Accessed May 2026.\n\n 7. American Cancer Society. What Is Bladder Cancer? Available at: \nhttps://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.cancer.org%2Fcancer%2Fbladder-cancer%2Fabout%2Fwhat-is-bladder-cancer.html&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fwww.cancer.org%2Fcancer%2Fbladder-cancer%2Fabout%2Fwhat-is-bladder-cancer.html&index=8&md5=af48d3c91950e27cb5b929c7fb53673a)\n\n. Accessed May 2026.\n\n 8. AstraZeneca PLC. Investor relations epidemiology spreadsheet. Available at: \nhttps://www.astrazeneca.com/investor-relations.html\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.astrazeneca.com%2Finvestor-relations.html&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fwww.astrazeneca.com%2Finvestor-relations.html&index=9&md5=d61bcd70afa75f39ef0532dc7128f5fc)\n\n. Accessed May 2026.\n\n 9. AstraZeneca PLC. Imfinzi approved in the US as first and only perioperative\nimmunotherapy for patients with muscle-invasive bladder cancer. Available at: \nhttps://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2025%2Fimfinzi-approved-in-the-us-for-bladder-cancer.html&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2025%2Fimfinzi-approved-in-the-us-for-bladder-cancer.html&index=10&md5=2c247ca80051ff0c4b6a223062d05dd1)\n\n. Accessed May 2026.\n\nUS-112845 Last Updated 5/26\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260514820907/en/\n(https://www.businesswire.com/news/home/20260514820907/en/)\n\nMedia Inquiries \n\nLauren-Jei McCarthy +1 347 918 7001\n\n\n\nUS Media Mailbox: usmediateam@astrazeneca.com\n(mailto:usmediateam@astrazeneca.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw8nLwFRa","title":"Perioperative IMFINZI® (durvalumab) plus neoadjuvant EV showed statistically significant and clinically meaningful improvements in event-free survival and overall survival in muscle-invasive bladder cancer in the Phase III VOLGA trial","author":"Business Wire","ticker":"AZN","created":"2026-05-14T11:00:00.543Z","tickers":["AZN"],"exchange":"LSE","article_body":"Perioperative IMFINZI® (durvalumab) plus neoadjuvant EV showed statistically\nsignificant and clinically meaningful improvements in event-free survival and\noverall survival in muscle-invasive bladder cancer in the Phase III VOLGA\ntrial\n\nPerioperative IMFINZI plus IMJUDO® (tremelimumab-actl) and neoadjuvant EV\nshowed a statistically significant and clinically meaningful improvement in\nevent-free survival and a favorable trend for overall survival\n\nHigh-level results from a planned interim analysis of the VOLGA Phase III\ntrial showed perioperative treatment with IMFINZI(®) (durvalumab) in\ncombination with neoadjuvant enfortumab vedotin (EV) demonstrated\nstatistically significant and clinically meaningful improvements in event-free\nsurvival (EFS) and overall survival (OS) in patients with muscle-invasive\nbladder cancer (MIBC) versus standard of care. Patients were ineligible for or\nhad declined cisplatin-based chemotherapy. Patients in the comparator arm had\na radical cystectomy (surgery to remove the bladder) with or without approved\nadjuvant treatment.\n\nPerioperative IMFINZI plus IMJUDO(®) (tremelimumab-actl) in combination with\nneoadjuvant EV demonstrated a statistically significant and clinically\nmeaningful improvement in EFS and a favorable trend for OS; however, the OS\ndata were not statistically significant at this planned interim analysis and\nwill be formally reassessed at a subsequent analysis.\n\nApproximately one in four patients with bladder cancer has muscle-invasive\ndisease, where the tumor invades the muscle wall of the bladder, without\ndistant metastases.(1,2) As many as 50% of patients are ineligible for\ncisplatin-based chemotherapy due to impaired renal function or\ncomorbidities.(3,4) The standard treatment for these patients has historically\nbeen radical cystectomy alone but, despite undergoing this major surgery,\npatients experience high rates of recurrence and have a poor prognosis.(3-5)\n\nThomas Powles, MD, Professor, Chair of Barts Cancer Centre (QMUL), London, UK,\nand International Coordinating Investigator for the trial, said: “Up to half\nof patients with muscle-invasive bladder cancer are not eligible for cisplatin\nand face high rates of disease recurrence, even after having their bladder\nremoved, leaving a significant need for new effective and well-tolerated\ntreatments. The VOLGA results show that perioperative durvalumab significantly\nextends event-free survival and overall survival when combined with\nneoadjuvant enfortumab vedotin, with a manageable safety profile, compared to\nsurgery for patients in this curative-intent setting.”\n\nSusan Galbraith, Executive Vice President, Oncology Haematology R&D,\nAstraZeneca, said: “This interim analysis from the VOLGA trial highlights\nthe benefit of perioperative IMFINZI with neoadjuvant enfortumab vedotin\ncompared to surgery, a novel regimen that optimizes treatment options for\npatients. Together with NIAGARA and POTOMAC, VOLGA is our third positive\nreadout in bladder cancer, setting a strong foundation for IMFINZI as the\nimmunotherapy backbone in this early-stage, curative-intent setting.”\n\nThe safety and tolerability of IMFINZI with or without IMJUDO plus EV was\nconsistent with the known safety profiles of the individual medicines, with no\nnew safety signals identified. These data will be presented at a forthcoming\nmedical meeting and shared with global regulatory authorities.\n\nIMFINZI is approved in over 40 countries for patients with cisplatin-eligible\nMIBC, based on the NIAGARA Phase III trial. Additionally, IMFINZI added to\nBacillus Calmette-Guérin therapy met the primary endpoint of disease-free\nsurvival for patients with high-risk non-muscle-invasive bladder cancer in the\nPOTOMAC Phase III trial and is currently under review in the US, European\nUnion (EU), Japan and several other countries. IMFINZI is also being\ninvestigated in locally advanced or metastatic disease in the NILE Phase III\ntrial.\n\nIMPORTANT SAFETY INFORMATION\n\nThere are no contraindications for IMFINZI(®) (durvalumab) or IMJUDO(®)\n(tremelimumab-actl).\n\nSevere and Fatal Immune-Mediated Adverse Reactions\n\nImportant immune-mediated adverse reactions listed under Warnings and\nPrecautions may not include all possible severe and fatal immune-mediated\nreactions. Immune-mediated adverse reactions, which may be severe or fatal,\ncan occur in any organ system or tissue. Immune-mediated adverse reactions can\noccur at any time after starting treatment or after discontinuation. Monitor\npatients closely for symptoms and signs that may be clinical manifestations of\nunderlying immune-mediated adverse reactions. Evaluate clinical chemistries\nincluding liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level,\nand thyroid function at baseline and before each dose. In cases of suspected\nimmune-mediated adverse reactions, initiate appropriate workup to exclude\nalternative etiologies, including infection. Institute medical management\npromptly, including specialty consultation as appropriate. Withhold or\npermanently discontinue IMFINZI and IMJUDO depending on severity. See USPI\nDosing and Administration for specific details. In general, if IMFINZI and\nIMJUDO requires interruption or discontinuation, administer systemic\ncorticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until\nimprovement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate\ncorticosteroid taper and continue to taper over at least 1 month. Consider\nadministration of other systemic immunosuppressants in patients whose\nimmune-mediated adverse reactions are not controlled with corticosteroid\ntherapy.\n\nImmune-Mediated Pneumonitis\n\nIMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal.\nThe incidence of pneumonitis is higher in patients who have received prior\nthoracic radiation.\n\n\n * IMFINZI as a Single Agent\n\n\n* In patients who did not receive recent prior radiation, the incidence of\nimmune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%),\nand Grade 3-4 (0.4%) adverse reactions.\n\n * In patients who received recent prior radiation, the incidence of pneumonitis\n(including radiation pneumonitis) in patients with unresectable Stage III\nNSCLC following definitive chemoradiation within 42 days prior to initiation\nof IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and\n12.8% (30/234) in patients receiving placebo. Of the patients who received\nIMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.\n\n * The incidence of pneumonitis (including radiation pneumonitis) in patients\nwith LS-SCLC following chemoradiation within 42 days prior to initiation of\nIMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6%\n(16/265) in patients receiving placebo. Of the patients who received IMFINZI\n(262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse\nreactions.\n\n * The frequency and severity of immune-mediated pneumonitis in patients who did\nnot receive definitive chemoradiation prior to IMFINZI were similar in\npatients who received IMFINZI as a single agent or with ES-SCLC or BTC when\ngiven in combination with chemotherapy.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving\nIMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse\nreactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nfatal (0.5%), and Grade 3 (1%) adverse reactions.\n\n\n\n\nImmune-Mediated Colitis\n\nIMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated\ncolitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated\ncolitis that is frequently associated with diarrhea. Cytomegalovirus (CMV)\ninfection/reactivation has been reported in patients with\ncorticosteroid-refractory immune-mediated colitis. In cases of\ncorticosteroid-refractory colitis, consider repeating infectious workup to\nexclude alternative etiologies.\n\n\n * IMFINZI as a Single Agent\n\n\n* Immune-mediated colitis occurred in 2% (37/1889) of patients receiving\nIMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients\nreceiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.\nIntestinal perforation has been observed in other studies of IMFINZI and\nIMJUDO.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy including\nfatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and\nlarge intestine perforation were reported in 0.1% of patients.\n\n\n\n\nImmune-Mediated Hepatitis\n\nIMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.\n\n\n * IMFINZI as a Single Agent\n\n\n* Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving\nIMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse\nreactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving\nIMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%)\nadverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nfatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.\n\n\n\n\nImmune-Mediated Endocrinopathies\n\n\n * Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary\nadrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate\nsymptomatic treatment, including hormone replacement as clinically indicated.\n\n\n* IMFINZI as a Single Agent\n\n\n* Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients\nreceiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients\nreceiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients\nreceiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy,\nincluding Grade 3 (0.8%) adverse reactions.\n\n\n\n\n\n\n\n * Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis.\nHypophysitis can present with acute symptoms associated with mass effect such\nas headache, photophobia, or visual field cuts. Hypophysitis can cause\nhypopituitarism. Initiate symptomatic treatment including hormone replacement\nas clinically indicated.\n\n\n* IMFINZI as a Single Agent\n\n\n* Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of\npatients\nwho received IMFINZI.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of\npatients receiving IMFINZI and IMJUDO.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.5%) adverse reactions.\n\n\n\n\n\n\n\n * Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism): IMFINZI\nand IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can\npresent with or without endocrinopathy. Hypothyroidism can follow\nhyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or\ninstitute medical management of hyperthyroidism as clinically indicated.\n\n\n* IMFINZI as a Single Agent\n\n\n* Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving\nIMFINZI, including Grade 3 (<0.1%) adverse reactions.\n\n * Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients\nreceiving IMFINZI.\n\n * Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients\nreceiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving\nIMFINZI and IMJUDO.\n\n * Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients\nreceiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.\n\n * Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving\nIMFINZI and IMJUDO.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy.\n\n * Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.2%) adverse reactions.\n\n * Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.5%) adverse reactions.\n\n\n\n\n * IMFINZI with Carboplatin and Paclitaxel\n\n\n* Immune-mediated hypothyroidism occurred in 14% (34/235) of patients\nreceiving\nIMFINZI in combination with carboplatin and paclitaxel.\n\n\n\n\n\n\n\n * Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis:\nMonitor patients for hyperglycemia or other signs and symptoms of diabetes.\nInitiate treatment with insulin as clinically indicated.\n\n\n* IMFINZI as a Single Agent\n\n\n* Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1%\n(1/1889)\nof patients receiving IMFINZI.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin\ntherapy that had not resolved at last follow-up.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of\npatients\nreceiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy\nincluding Grade 3 (0.3%) adverse reactions.\n\n\n\n\n\n\n\nImmune-Mediated Nephritis with Renal Dysfunction\n\nIMFINZI and IMJUDO can cause immune-mediated nephritis.\n\n\n * IMFINZI as a Single Agent\n\n\n* Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving\nIMFINZI, including Grade 3 (<0.1%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated nephritis occurred in 1% (4/388) of patients receiving\nIMFINZI\nand IMJUDO, including Grade 3 (0.5%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.2%) adverse reactions.\n\n\n\n\nImmune-Mediated Dermatology Reactions\n\nIMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative\ndermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with\neosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis\n(TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical\nemollients and/or topical corticosteroids may be adequate to treat mild to\nmoderate non-exfoliative rashes.\n\n\n * IMFINZI as a Single Agent\n\n\n* Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients\nreceiving IMFINZI, including Grade 3 (0.4%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients\nreceiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%)\nadverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients\nreceiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy,\nincluding Grade 3 (0.3%) adverse reactions.\n\n\n\n\nImmune-Mediated Pancreatitis\n\nIMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis.\nImmune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving\nIMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse\nreactions.\n\nOther Immune-Mediated Adverse Reactions\n\nThe following clinically significant, immune-mediated adverse reactions\noccurred at an incidence of less than 1% each in patients who received IMFINZI\nand IMJUDO or were reported with the use of other immune-checkpoint\ninhibitors.\n\n\n * Cardiac/vascular: Myocarditis, pericarditis, vasculitis.\n\n * Nervous system: Meningitis, encephalitis, myelitis and demyelination,\nmyasthenic syndrome/myasthenia gravis (including exacerbation),\nGuillain-Barré syndrome, nerve paresis, autoimmune neuropathy.\n\n * Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur.\nSome cases can be associated with retinal detachment. Various grades of visual\nimpairment to include blindness can occur. If uveitis occurs in combination\nwith other immune-mediated adverse reactions, consider a\nVogt-Koyanagi-Harada-like syndrome, as this may require treatment with\nsystemic steroids to reduce the risk of permanent vision loss.\n\n * Gastrointestinal: Pancreatitis including increases in serum amylase and lipase\nlevels, gastritis, duodenitis.\n\n * Musculoskeletal and connective tissue disorders: Myositis/polymyositis,\nrhabdomyolysis and associated sequelae including renal failure, arthritis,\npolymyalgia rheumatic.\n\n * Endocrine: Hypoparathyroidism.\n\n * Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic\nlymphohistiocytosis, systemic inflammatory response syndrome, histiocytic\nnecrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune\nthrombocytopenia, solid organ transplant rejection, other transplant\n(including corneal graft) rejection.\n\nInfusion-Related Reactions\n\nIMFINZI and IMJUDO can cause severe or life-threatening infusion-related\nreactions. Monitor for signs and symptoms of infusion-related reactions.\nInterrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO\nbased on the severity. See USPI Dosing and Administration for specific\ndetails. For Grade 1 or 2 infusion-related reactions, consider using\npre-medications with subsequent doses.\n\n\n * IMFINZI as a Single Agent\n\n\n* Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving\nIMFINZI, including Grade 3 (0.3%) adverse reactions.\n\n\n\n\n * IMFINZI with IMJUDO\n\n\n* Infusion-related reactions occurred in 2.6% (10/388) of patients receiving\nIMFINZI and IMJUDO.\n\n\n\n\n * IMFINZI with IMJUDO and Platinum-Based Chemotherapy\n\n\n* Infusion-related reactions occurred in 2.9% (17/596) of patients receiving\nIMFINZI in combination with IMJUDO and platinum-based chemotherapy, including\nGrade 3 (0.3%) adverse reactions.\n\n\n\n\nComplications of Allogeneic HSCT after IMFINZI\n\nFatal and other serious complications can occur in patients who receive\nallogeneic hematopoietic stem cell transplantation (HSCT) before or after\nbeing treated with a PD-1/L-1 blocking antibody. Transplant-related\ncomplications include hyperacute graft-versus-host disease (GVHD), acute GVHD,\nchronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity\nconditioning, and steroid-requiring febrile syndrome (without an identified\ninfectious cause). These complications may occur despite intervening therapy\nbetween PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for\nevidence of transplant-related complications and intervene promptly. Consider\nthe benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior\nto or after an allogeneic HSCT.\n\nEmbryo-Fetal Toxicity\n\nBased on their mechanism of action and data from animal studies, IMFINZI and\nIMJUDO can cause fetal harm when administered to a pregnant woman. Advise\npregnant women of the potential risk to a fetus. In females of reproductive\npotential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and\nadvise them to use effective contraception during treatment with IMFINZI and\nIMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.\n\nLactation\n\nThere is no information regarding the presence of IMFINZI and IMJUDO in human\nmilk; however, because of the potential for serious adverse reactions in\nbreastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed\nduring treatment and for 3 months after the last dose.\n\nAdverse Reactions\n\nUnresectable Stage III NSCLC\n\n\n * In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI\n(n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue\n(34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract\ninfections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4\nadverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation\npneumonitis (3.4%).\n\n * In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI\n(n=475), discontinuation due to adverse reactions occurred in 15% of patients\nin the IMFINZI arm. Serious adverse reactions occurred in 29% of patients\nreceiving IMFINZI. The most frequent serious adverse reactions (≥2%) were\npneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal\npneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of\npatients and were similar across arms.\n\nResectable NSCLC\n\n\n * In patients with resectable NSCLC in the AEGEAN study, the most common adverse\nreactions (occurring in ≥20% of patients) were anemia, nausea, constipation,\nfatigue, musculoskeletal pain, and rash.\n\n * In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study\nreceiving IMFINZI in combination with platinum-containing chemotherapy\n(n=401), permanent discontinuation of IMFINZI due to an adverse reaction\noccurred in 6.7% of patients. Serious adverse reactions occurred in 21% of\npatients. The most frequent (≥1%) serious adverse reactions were pneumonia\n(2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia\n(1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of\npatients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%),\nmyocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death\nnot otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who\nreceived neoadjuvant treatment and 398 placebo-treated patients who received\nneoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive\nsurgery due to adverse reactions.\n\n * In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study\nreceiving IMFINZI as a single agent (n=265), permanent discontinuation of\nIMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse\nreactions occurred in 13% of patients. The most frequent serious adverse\nreactions reported in >1% of patients were pneumonia (1.9%), pneumonitis\n(1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the\nadjuvant phase of the study, including COVID-19 pneumonia, pneumonia\naspiration, interstitial lung disease and aortic aneurysm.\n\nMetastatic NSCLC\n\n\n * In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO\nplus platinum-based chemotherapy (n=330), the most common adverse reactions\n(occurring in ≥20% of patients) were nausea (42%), fatigue (36%),\nmusculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea\n(22%).\n\n * In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination\nwith IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation\nof IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients.\nSerious adverse reactions occurred in 44% of patients, with the most frequent\nserious adverse reactions reported in at least 2% of patients being pneumonia\n(11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%),\nand febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of\n4.2% of patients.\n\nLimited-stage Small Cell Lung Cancer\n\n\n * In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI\n(n=262), the most common adverse reactions occurring in ≥20% of patients\nreceiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue\n(21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis\nor radiation pneumonitis and pneumonia.\n\n * In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI\n(n=262), IMFINZI was permanently discontinued due to adverse reactions in 16%\nof the patients receiving IMFINZI. Serious adverse reactions occurred in 30%\nof patients receiving IMFINZI. The most frequent serious adverse reactions\nreported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation\npneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in\n2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac\nfailure, encephalopathy and pneumonitis (0.4% each).\n\nExtensive-stage Small Cell Lung Cancer\n\n\n * In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI\nplus chemotherapy (n=265), the most common adverse reactions (≥20%) were\nnausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common\nGrade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%).\n\n * In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI\nplus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions\nin 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse\nreactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The\nmost frequent serious adverse reactions reported in at least 1% of patients\nwere febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia\n(1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred\nin 4.9% of patients receiving IMFINZI plus chemotherapy.\n\nLocally Advanced or Metastatic Biliary Tract Cancers\n\n\n * In patients with locally advanced or metastatic BTC in the TOPAZ-1 study\nreceiving IMFINZI (n=338), the most common adverse reactions (occurring in\n≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%),\ndecreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).\n\n * In patients with locally advanced or metastatic BTC in the TOPAZ-1 study\nreceiving IMFINZI (n=338), discontinuation due to adverse reactions occurred\nin 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse\nreactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The\nmost frequent serious adverse reactions reported in at least 2% of patients\nwere cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%) and acute\nkidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients\nreceiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic\nstroke (4 patients), sepsis (2 patients), and upper gastrointestinal\nhemorrhage (2 patients).\n\nUnresectable Hepatocellular Carcinoma\n\n\n * In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and\nIMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of\npatients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%),\nmusculoskeletal pain (22%), and abdominal pain (20%).\n\n * In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and\nIMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious\nadverse reactions in >1% of patients included hemorrhage (6%), diarrhea\n(4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute\nkidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in\n8% of patients who received IMFINZI and IMJUDO, including death (1%),\nhemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%),\nhepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent\ndiscontinuation of treatment regimen due to an adverse reaction occurred in\n14% of patients.\n\nPrimary advanced or Recurrent dMMR Endometrial Cancer\n\n\n * In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E\nstudy receiving IMFINZI in combination with carboplatin and paclitaxel\nfollowed by IMFINZI as a single agent (n=44), the most common adverse\nreactions, including laboratory abnormalities (occurring in >20% of\npatients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea\n(59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation\n(39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased\nAST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium\n(25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%),\nand decreased appetite (18%). The most common Grade 3 or 4 adverse reactions\n(≥3%) were constipation (4.5%) and fatigue (4.5%).\n\n * In patients with advanced or recurrent dMMR endometrial cancer in the DUO-E\nstudy receiving IMFINZI in combination with carboplatin and paclitaxel\nfollowed by IMFINZI as a single agent (n=44), permanent discontinuation of\nIMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse\nreactions occurred in 30% of patients who received IMFINZI with carboplatin\nand paclitaxel; the most common serious adverse reactions (≥4%) were\nconstipation (4.5%) and rash (4.5%).\n\nMuscle-Invasive Bladder Cancer (MIBC)\n\n\n * In patients with MIBC, the most common adverse reactions, including laboratory\nabnormalities, in the overall study (occurring in ≥20% of patients) were\ndecreased hemoglobin, decreased neutrophils, increased blood creatinine,\ndecreased sodium, nausea, increased ALT, decreased calcium, decreased\nplatelets, fatigue, increased potassium, decreased lymphocytes, increased AST,\nconstipation, decreased magnesium, decreased appetite, increased alkaline\nphosphate, rash, pyrexia, diarrhea, vomiting and abdominal pain.\n\n * In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving\nIMFINZI in combination with gemcitabine and cisplatin (n=530), permanent\ndiscontinuation of IMFINZI due to an adverse reaction occurred in 9% of\npatients. Serious adverse reactions occurred in 24% of patients; the most\nfrequent (≥1%) serious adverse reactions were pulmonary embolism (1.9%),\nfebrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia\n(1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse\nreactions occurred in 1.1% of patients including sepsis, myocardial\ninfarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of\npneumonia was reported in 1 (0.2%) patient in the post-surgery phase before\nadjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm\nand 526 patients in the chemotherapy treatment arm who received neoadjuvant\ntreatment, 1 (0.2%) patient in each treatment arm did not receive surgery due\nto adverse reactions. The adverse reaction that led to cancellation of surgery\nin the IMFINZI treatment arm was interstitial lung disease.\n\n * In patients with MIBC in the adjuvant phase of the NIAGARA study receiving\nIMFINZI as a single agent (n=383), permanent discontinuation of adjuvant\nIMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse\nreactions occurred in 26% of patients. The most frequent serious adverse\nreactions (occurring in ≥1% of patients) were urinary tract infection (7%),\nacute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%),\nurosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8%\nof patients, including COVID-19, severe acute respiratory syndrome,\ncardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic\nfailure (0.3% each).\n\nResectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)\n\n\n * In patients with resectable GC/GEJC, the most common adverse reactions in the\noverall study (occurring in ≥20% of patients) were diarrhea, nausea,\nperipheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal\npain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.\n\n * In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN\nstudy receiving IMFINZI in combination with FLOT chemotherapy (n=475),\npermanent discontinuation of IMFINZI due to an adverse reaction occurred in\n2.5% of patients. Serious adverse reactions occurred in 21% of patients; the\nmost frequent (≥2%) serious adverse reaction was diarrhea (2.5%). Deaths\noccurred in 1.9% of patients; deaths ≥2 patients included septic shock\n(0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI\n+ FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT\nchemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4%\nof patients, respectively, did not receive surgery due to adverse reactions,\nand 2.3% and 2.6% of patients, respectively, had a delay in surgery due to\nARs.\n\n * In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN\nstudy receiving IMFINZI in combination with FLOT chemotherapy (n=365),\npermanent discontinuation of IMFINZI due to an adverse reaction occurred in 7%\nof patients. Serious adverse reactions occurred in 29% of patients; the most\nfrequent (≥2%) serious adverse reaction was pneumonia (2.5%). Deaths\noccurred in 2.2% of patients; deaths ≥2 patients included gastrointestinal\nperforation (0.5%) and COVID-19 (0.5%).\n\n * In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN\nstudy receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI\ndue to an adverse reaction occurred in 6% of patients. Serious adverse\nreactions occurred in 14% of patients. Deaths occurred in 1.7% of patients;\ndeaths ≥2 patients included gastrointestinal perforation (0.6%) and COVID-19\n(0.6%).\n\nThe safety and effectiveness of IMFINZI and IMJUDO have not been established\nin pediatric patients.\n\nIndications:\n\nIMFINZI, as a single agent, is indicated for the treatment of adult patients\nwith unresectable Stage III non-small cell lung cancer (NSCLC) whose disease\nhas not progressed following concurrent platinum-based chemotherapy and\nradiation therapy (cCRT).\n\nIMFINZI in combination with platinum-containing chemotherapy as neoadjuvant\ntreatment, followed by IMFINZI continued as a single agent as adjuvant\ntreatment after surgery, is indicated for the treatment of adult patients with\nresectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal\ngrowth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)\nrearrangements.\n\nIMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is\nindicated for the treatment of adult patients with metastatic NSCLC with no\nsensitizing EGFR mutations or ALK genomic tumor aberrations.\n\nIMFINZI, as a single agent, is indicated for the treatment of adult patients\nwith limited-stage small cell lung cancer (LS-SCLC) whose disease has not\nprogressed following concurrent platinum-based chemotherapy and radiation\ntherapy (cCRT).\n\nIMFINZI, in combination with etoposide and either carboplatin or cisplatin, is\nindicated for the first-line treatment of adult patients with extensive-stage\nsmall cell lung cancer (ES-SCLC).\n\nIMFINZI, in combination with gemcitabine and cisplatin, is indicated for the\ntreatment of adult patients with locally advanced or metastatic biliary tract\ncancer (BTC).\n\nIMFINZI in combination with IMJUDO is indicated for the treatment of adult\npatients with unresectable hepatocellular carcinoma (uHCC).\n\nIMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as\na single agent is indicated for the treatment of adult patients with primary\nadvanced or recurrent endometrial cancer that is mismatch repair deficient\n(dMMR) as determined by an FDA-approved test.\n\nIMFINZI in combination with gemcitabine and cisplatin as neoadjuvant\ntreatment, followed by single agent IMFINZI as adjuvant treatment following\nradical cystectomy, is indicated for the treatment of adult patients with\nmuscle-invasive bladder cancer (MIBC).\n\nIMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and\ndocetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single\nagent IMFINZI, is indicated for the treatment of adult patients with\nresectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).\n\nPlease see Full Prescribing Information including Medication Guide for IMFINZI\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdrd9vrdh9yh09.cloudfront.net%2F50fd68b9-106b-4550-b5d0-12b045f8b184%2F9496217c-08b3-432b-ab4f-538d795820bd%2F9496217c-08b3-432b-ab4f-538d795820bd_viewable_rendition__v.pdf&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=IMFINZI&index=1&md5=a85a2955e69b19fafb75f06f0ad6bdb0)\nand IMJUDO\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdrd9vrdh9yh09.cloudfront.net%2F50fd68b9-106b-4550-b5d0-12b045f8b184%2F0102c6fd-de8a-4b43-afa3-2a2c2115d472%2F0102c6fd-de8a-4b43-afa3-2a2c2115d472_viewable_rendition__v.pdf&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=IMJUDO&index=2&md5=ac45e910f4ba462f9dfc56aaf50e3905)\n.\n\nNotes\n\nBladder cancer\n\nBladder cancer is the 9th most common cancer in the world, with more than\n614,000 cases diagnosed each year.(6) The most common type is urothelial\ncarcinoma, which begins in the urothelial cells of the urinary tract.( 7)\n\nIn 2024, an estimated 117,500 patients were treated for MIBC with the standard\nof care, which included neoadjuvant cisplatin-based chemotherapy and radical\ncystectomy.(5,8) In 2025, the NIAGARA Phase III trial established a new\nstandard by adding perioperative IMFINZI to the regimen.(9) However, up to\nhalf of patients are not eligible to receive cisplatin, and approximately 50%\nof MIBC patients who undergo bladder removal surgery experience disease\nrecurrence.(3,5) New treatment options that prevent both progression before\nsurgery and recurrence after surgery are critically needed in this\ncurative-intent setting.\n\nVOLGA\n\nVOLGA is a Phase III, randomized, open-label, multi-center global trial\nevaluating perioperative IMFINZI(®) (durvalumab) with or without IMJUDO(®)\n(tremelimumab-actl) in combination with neoadjuvant EV as treatment for\npatients with MIBC undergoing radical cystectomy who are not eligible for or\nhave declined cisplatin compared to radical cystectomy with or without\napproved adjuvant therapy. In the trial, 695 patients were randomized 1:1:1 to\nArm 1 (three cycles of IMFINZI and EV, plus two cycles of IMJUDO prior to\nsurgery, followed by nine cycles of IMFINZI plus one cycle of IMJUDO as\nadjuvant therapy), Arm 2 (three cycles of IMFINZI and EV prior to surgery,\nfollowed by nine cycles of IMFINZI adjuvant monotherapy) and Arm 3, the\ncomparator arm.\n\nThe trial was conducted in 182 centers across 25 countries in Europe, North\nAmerica, South America and Asia. Its dual primary endpoints are EFS, defined\nas the time from randomization to first recurrence post-radical cystectomy,\nfirst progression in patients who did not undergo radical cystectomy, failure\nto undergo radical cystectomy in patients with residual disease or death due\nto any cause, for both experimental arms versus the comparator arm. Secondary\nendpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic\ncomplete response, disease-free survival and pathologic downstaging across\nboth experimental arms.\n\nIMFINZI\n\nIMFINZI(®) (durvalumab) is a human monoclonal antibody that binds to the\nPD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80\nproteins, countering the tumor’s immune-evading tactics and releasing the\ninhibition of immune responses.\n\nIn addition to its indication in MIBC, IMFINZI is the global standard of care\nbased on OS in the curative-intent setting of unresectable, Stage III\nnon-small cell lung cancer (NSCLC) in patients whose disease has not\nprogressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as\na perioperative treatment in combination with neoadjuvant chemotherapy in\nresectable NSCLC, and in combination with a short course of IMJUDO(®)\n(tremelimumab-actl) and chemotherapy for the treatment of metastatic NSCLC.\nIMFINZI is also approved for limited-stage small cell lung cancer (SCLC) in\npatients whose disease has not progressed following concurrent platinum-based\nCRT; and in combination with chemotherapy (etoposide and either carboplatin or\ncisplatin) for the treatment of extensive-stage SCLC.\n\nIn addition to its indications in lung cancers, IMFINZI is approved in\ncombination with chemotherapy (gemcitabine plus cisplatin) in locally advanced\nor metastatic biliary tract cancer and in combination with IMJUDO in\nunresectable hepatocellular carcinoma (HCC). IMFINZI is also approved as a\nmonotherapy in unresectable HCC in Japan and the EU. In resectable gastric and\ngastroesophageal junction cancers, perioperative IMFINZI added to\nstandard-of-care chemotherapy is approved in the US and EU. Additionally, in\nApril 2026, IMFINZI in combination with IMJUDO, lenvatinib and transarterial\nchemoembolization (TACE) demonstrated a statistically significant and\nclinically meaningful improvement in the primary endpoint of progression-free\nsurvival versus TACE alone for patients with unresectable HCC eligible for\nembolization in the EMERALD-3 Phase III trial.\n\nIMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is\napproved as a 1st-line treatment for primary advanced or recurrent endometrial\ncancer (mismatch repair deficient disease only in US and EU). IMFINZI in\ncombination with chemotherapy followed by olaparib and IMFINZI is approved for\npatients with mismatch repair proficient advanced or recurrent endometrial\ncancer in EU and Japan.\n\nSince the first approval in May 2017, more than 414,000 patients have been\ntreated with IMFINZI. As part of a broad development program, IMFINZI is being\ntested as a single treatment and in combinations with other anti-cancer\ntreatments for patients with SCLC, NSCLC, bladder cancer, breast cancer,\nseveral gastrointestinal and gynecologic cancers, and other solid tumors.\n\nIMJUDO\n\nIMJUDO(®) (tremelimumab-actl) is a human monoclonal antibody that targets the\nactivity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). IMJUDO\nblocks the activity of CTLA-4, contributing to T-cell activation, priming the\nimmune response to cancer and fostering cancer cell death. In addition to its\napproved indications in liver and lung cancers, IMJUDO is being tested in\ncombination with IMFINZI across other tumor types including SCLC (ADRIATIC)\nand bladder cancer (NILE).\n\nAstraZeneca in immuno-oncology (IO)\n\nAstraZeneca is a pioneer in introducing the concept of immunotherapy into\ndedicated clinical areas of high unmet medical need. The Company has a\ncomprehensive and diverse IO portfolio and pipeline anchored in\nimmunotherapies designed to overcome evasion of the anti-tumor immune response\nand stimulate the body’s immune system to attack tumors.\n\nAstraZeneca strives to redefine cancer care and help transform outcomes for\npatients with IMFINZI as a monotherapy and in combination with IMJUDO as well\nas other novel immunotherapies and modalities. The Company is also\ninvestigating next-generation immunotherapies like bispecific antibodies and\ntherapeutics that harness different aspects of immunity to target cancer,\nincluding cell therapy and T-cell engagers.\n\nAstraZeneca is pursuing an innovative clinical strategy to bring IO-based\ntherapies that deliver long-term survival to new settings across a wide range\nof cancer types. The Company is focused on exploring novel combination\napproaches to help prevent treatment resistance and drive longer immune\nresponses. With an extensive clinical program, the Company also champions the\nuse of IO treatment in earlier disease stages, where there is the greatest\npotential for cure.\n\nAstraZeneca in oncology\n\nAstraZeneca is leading a revolution in oncology with the ambition to provide\ncures for cancer in every form, following the science to understand cancer and\nall its complexities to discover, develop and deliver life-changing medicines\nto patients.\n\nThe Company’s focus is on some of the most challenging cancers. It is\nthrough persistent innovation that AstraZeneca has built one of the most\ndiverse portfolios and pipelines in the industry, with the potential to\ncatalyze changes in the practice of medicine and transform the patient\nexperience.\n\nAstraZeneca has the vision to redefine cancer care and, one day, eliminate\ncancer as a cause of death.\n\nAstraZeneca \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.astrazeneca-us.com%2F&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=AstraZeneca&index=3&md5=fe7416841d82e5b61aeeb441f683ee1a)\n\nAstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical\ncompany that focuses on the discovery, development, and commercialization of\nprescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals,\nincluding Cardiovascular, Renal & Metabolism, and Respiratory &\nImmunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are\nsold in more than 125 countries and used by millions of patients worldwide.\nPlease visit astrazeneca-us.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.astrazeneca-us.com%2F&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=astrazeneca-us.com&index=4&md5=92ae47cad538986c154d1856568aec7f)\nand follow the Company on social media @AstraZeneca\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fastrazeneca&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=%40AstraZeneca&index=5&md5=dc035a938124a6aab6432945147ce7db)\n. The contents of AstraZeneca’s website do not form part of this document\nand no one should rely on such websites or the contents thereof in reading\nthis document.\n\nReferences\n\n\n 1. Burger M, et al. Epidemiology and Risk Factors of Urothelial Bladder Cancer.\nEur Urol. 2013;63(2):234-241.\n\n 2. National Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and\nManagement. London: National Institute for Health and Care Excellence (NICE).\nAvailable at: \nhttps://www.ncbi.nlm.nih.gov/books/NBK356289/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK356289%2F&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK356289%2F&index=6&md5=7153038846a16ef7ca891e4e6cc83207)\n\n. Accessed May 2026.\n\n 3. Dash A, et al. Impact of renal impairment on eligibility for adjuvant\ncisplatin-based chemotherapy in patients with urothelial carcinoma of the\nbladder. Cancer. 2006;107(3):506-513.\n\n 4. Galsky MD, et al. Treatment of patients with metastatic urothelial cancer\n“unfit” for cisplatin-based chemotherapy. J Clin Oncol.\n2011;29(17):2432-2438.\n\n 5. Van der Heijden AG, et al. EAU Guidelines on Muscle-invasive and Metastatic\nBladder Cancer. 2026. Edn. Presented at the EAU Annual Congress Copenhagen\n2026. ISBN 978-94-92671-30-1.\n\n 6. World Health Organization. International Agency for Research on Cancer.\nBladder Fact Sheet. Available at: \nhttps://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fgco.iarc.who.int%2Fmedia%2Fglobocan%2Ffactsheets%2Fcancers%2F30-bladder-fact-sheet.pdf&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fgco.iarc.who.int%2Fmedia%2Fglobocan%2Ffactsheets%2Fcancers%2F30-bladder-fact-sheet.pdf&index=7&md5=6aecaf4f857024cbcf411266f2340fa4)\n\n. Accessed May 2026.\n\n 7. American Cancer Society. What Is Bladder Cancer? Available at: \nhttps://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.cancer.org%2Fcancer%2Fbladder-cancer%2Fabout%2Fwhat-is-bladder-cancer.html&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fwww.cancer.org%2Fcancer%2Fbladder-cancer%2Fabout%2Fwhat-is-bladder-cancer.html&index=8&md5=af48d3c91950e27cb5b929c7fb53673a)\n\n. Accessed May 2026.\n\n 8. AstraZeneca PLC. Investor relations epidemiology spreadsheet. Available at: \nhttps://www.astrazeneca.com/investor-relations.html\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.astrazeneca.com%2Finvestor-relations.html&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fwww.astrazeneca.com%2Finvestor-relations.html&index=9&md5=d61bcd70afa75f39ef0532dc7128f5fc)\n\n. Accessed May 2026.\n\n 9. AstraZeneca PLC. Imfinzi approved in the US as first and only perioperative\nimmunotherapy for patients with muscle-invasive bladder cancer. Available at: \nhttps://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2025%2Fimfinzi-approved-in-the-us-for-bladder-cancer.html&esheet=54535769&newsitemid=20260514820907&lan=en-US&anchor=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2025%2Fimfinzi-approved-in-the-us-for-bladder-cancer.html&index=10&md5=2c247ca80051ff0c4b6a223062d05dd1)\n\n. Accessed May 2026.\n\nUS-112845 Last Updated 5/26\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260514820907/en/\n(https://www.businesswire.com/news/home/20260514820907/en/)\n\nMedia Inquiries \n\nLauren-Jei McCarthy +1 347 918 7001\n\n\n\nUS Media Mailbox: usmediateam@astrazeneca.com\n(mailto:usmediateam@astrazeneca.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-05-14T11:00:01.122296179Z","server_sent_at_ms":1778756401122},"received_at":"2026-05-14T11:00:01.357Z","source_url":"https://www.businesswire.com/news/home/20260514820907/en/"},"analysis":{"id":"24584","press_release_id":"34623","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"AstraZeneca announced that the Phase III VOLGA trial demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.\n\nThe trial compared perioperative treatment with IMFINZI plus neoadjuvant enfortumab vedotin (EV) to the standard of care, which is radical cystectomy with or without approved adjuvant therapy.\n\nThe results show that perioperative IMFINZI plus IMJUDO and neoadjuvant EV significantly extended EFS and showed a favorable trend for OS, though the OS data were not statistically significant at this interim analysis.\n\nThese findings could lead to a new standard of care for MIBC, particularly for patients who cannot receive cisplatin-based chemotherapy, and set a strong foundation for IMFINZI in this curative-intent setting.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"AstraZeneca's Phase III VOLGA trial shows significant survival benefits for muscle-invasive bladder cancer, potentially reshaping the treatment landscape."},"keyFigures":{"drugName":"IMFINZI (durvalumab)","phaseOfTrial":"Phase III","customDimensions":{"comparator_arm":"radical cystectomy with or without approved adjuvant therapy","patients_treated":695}},"quotedText":"Up to half of patients with muscle-invasive bladder cancer are not eligible for cisplatin and face high rates of disease recurrence, even after having their bladder removed, leaving a significant need for new effective and well-tolerated treatments. The VOLGA results show that perioperative durvalumab significantly extends event-free survival and overall survival when combined with neoadjuvant enfortumab vedotin, with a manageable safety profile, compared to surgery for patients in this curative-intent setting.","namedEntities":{"people":[{"name":"Thomas Powles, MD","role":"Professor, Chair of Barts Cancer Centre (QMUL), London, UK, and International Coordinating Investigator for the trial"},{"name":"Susan Galbraith","role":"Executive Vice President, Oncology Haematology R&D, AstraZeneca"}],"products":["IMFINZI (durvalumab)","IMJUDO (tremelimumab-actl)","enfortumab vedotin (EV)"],"companies":[{"name":"AstraZeneca","ticker":"AZN","relationship":"issuer"}],"dollarAmounts":[]},"materialImpact":{"score":5,"reasoning":"The Phase III VOLGA trial showed statistically significant and clinically meaningful improvements in event-free survival and overall survival for muscle-invasive bladder cancer, which is a critical unmet need. This could lead to a new standard of care and significant commercial opportunity."},"tickerRelevance":{"others":[],"primary":"AZN"},"globalImportance":75,"audienceRelevance":80,"eventTypeSecondary":["product_launch"],"importanceComponents":{"tickerTier":"large-cap","eventGravity":"Phase III trial success","issuerAuthored":true,"unmetMedicalNeed":"muscle-invasive bladder cancer"}},"event_type":"clinical_trial","event_type_secondary":["product_launch"],"sentiment":"bullish","material_impact_score":5,"narrative":"AstraZeneca announced that the Phase III VOLGA trial demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.\n\nThe trial compared perioperative treatment with IMFINZI plus neoadjuvant enfortumab vedotin (EV) to the standard of care, which is radical cystectomy with or without approved adjuvant therapy.\n\nThe results show that perioperative IMFINZI plus IMJUDO and neoadjuvant EV significantly extended EFS and showed a favorable trend for OS, though the OS data were not statistically significant at this interim analysis.\n\nThese findings could lead to a new standard of care for MIBC, particularly for patients who cannot receive cisplatin-based chemotherapy, and set a strong foundation for IMFINZI in this curative-intent setting.","key_figures":{"drugName":"IMFINZI (durvalumab)","phaseOfTrial":"Phase III","customDimensions":{"comparator_arm":"radical cystectomy with or without approved adjuvant therapy","patients_treated":695}},"named_entities":{"people":[{"name":"Thomas Powles, MD","role":"Professor, Chair of Barts Cancer Centre (QMUL), London, UK, and International Coordinating Investigator for the trial"},{"name":"Susan Galbraith","role":"Executive Vice President, Oncology Haematology R&D, AstraZeneca"}],"products":["IMFINZI (durvalumab)","IMJUDO (tremelimumab-actl)","enfortumab vedotin (EV)"],"companies":[{"name":"AstraZeneca","ticker":"AZN","relationship":"issuer"}],"dollarAmounts":[]},"model_name":"Qwen/Qwen2.5-72B-Instruct-AWQ","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-05-14T12:16:32.670Z","global_importance":75,"audience_relevance":80,"importance_components":{"tickerTier":"large-cap","eventGravity":"Phase III trial success","issuerAuthored":true,"unmetMedicalNeed":"muscle-invasive bladder cancer"}},"durationMs":113335,"modelName":"george-droid-qwen-72b"}}